BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17395677 · Received July 26, 2023

    Report

    Report Number
    2518422-2023-16801
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    January 5, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: SERVEI CATALA DE SALUT TRAVESSERA DE LES CORTS 131-159 BARCELONAM08 08028 H10: THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS FIELD SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THE BATTERY WAS NOT FUNCTIONING. MULTIPLE GOOD FAITH EFFORTS (GFE) WERE ATTEMPTED TO OBTAIN INFORMATION ABOUT THE DEVICE USE AT THE TIME OF THE EVENT. NO RESPONSE OR FURTHER INFORMATION WAS RECEIVED FROM THE CUSTOMER REGARDING IF THE DEVICE WAS IN USE OR OUT OF USE AT THE TIME OF THE EVENT. PHILIPS WAS UNABLE TO CONFIRM THE FINAL DISPOSITION OF THE DEVICE BECAUSE THE CUSTOMER ALLOWED THE QUOTE TO EXPIRE, REFUSING SERVICE. NO FURTHER WORK WAS PERFORMED BY PHILIPS TO RESOLVE THE ISSUE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. H11: UPDATED CONTACT INFORMATION, CONTACT OFFICE ENTITY, AND MANUFACTURING SITE. THIS REPORT IS BEING SUBMITTED AS PART OF A CORRECTIVE ACTION TO REPLACE MANUFACTURER REPORT # 2031642-2023-00212. ALL INFORMATION FROM THE ORIGINAL REPORT(S) HAS BEEN TRANSFERRED TO THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BATTERY WAS NOT FUNCTIONING. UNKNOWN IF IN CLINICAL USE. NO REPORTS OF PATIENT/USER HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604894 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown